GMP Manufacturing Core Shared Resource ABSTRACT The GMP Manufacturing Core Facility at City of Hope offers both biological and chemical GMP manufacturing capabilities. The biological facilities consist of the Biologics & Cellular GMP Manufacturing Center, comprising the Center for Biomedicine and Genetics (CBG) and the Cell Therapy Production Center (CTPC). The Chemical GMP Synthesis Facility (CGSF) is a stand-alone operation providing state-of-the-art biopolymer and small molecule manufacturing. COH is the only Cancer Center in the US to provide both biological and chemical GMP manufacturing at a single institution. These facilities provide process development, regulatory support, and cGMP-compliant clinical-grade production of CAR T cell products, stem cell-based regenerative medicine products, monoclonal antibodies, lentiviral vectors, vaccines, and complex molecules including, biopolymers (peptides, siRNA-aptamers, DNA-peptide hybrids), nanomaterials, and natural products. Opened in 2000, the CBG is a fully cGMP-compliant 20,000 square foot preclinical and Phase I/II pilot manufacturing facility with 10,000 square feet of classified production space. In addition to being multi-product capable, it is the nation?s pre-eminent multi-process academic facility capable of simultaneously producing cGMP-compliant clinical-grade products in sufficient quantities for preclinical studies and early stage clinical trials. The CBG supports COH investigators in the production of viral vectors and modified cell products (CAR T cells; gene-modified CD34+ cells; gene-modified neural stem cells) that are currently in Phase I clinical trials for indications including CD19+ malignancies, AML, GBM, and AIDs-related lymphoma. The CTPC is also cGMP-compliant and opened in 2010 to meet additional demand for cell therapeutics. The CTPC provides 6,800 sq. ft. of production space and is capable of simultaneous multi-product and multi-process manufacturing. The state-of-the-art CGSF (established in 2012) manufactures small and large molecule therapeutics. It also produces nanomaterials, complex natural products, and biopolymers, such as peptides, siRNA-aptamers, DNA- peptide hybrids. The CGSF provides services including: drug discovery, process research, development, and early clinical manufacturing of pharmaceutical drug substances (APIs). The facility is designed with three independent manufacturing suites to produce API that meets Food and Drug Administration requirements and on sufficient scales (gram to kilogram) for preclinical toxicology studies and Phase I/II clinical trials. The GMP Manufacturing Core is co-directed by Joseph Gold, PhD, David Horne, PhD, and Dr. David Hsu. Over the past five years, the Core was used by a total of 28 unique investigators, including ten CC members and eight NCI-designated Cancer Centers. In addition, 553 products were manufactured and 7 separate cancer clinical trials were supported by the Core.